Cromolyn Sodium Nasal Solution
» Cromolyn Sodium Nasal Solution is an aqueous solution of Cromolyn Sodium. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C23H14Na2O11. It may contain suitable stabilizers.
Packaging and storage
Preserve in tight, light-resistant containers.
Identification
It meets the requirements for Identification test B under Cromolyn Sodium.
pH 791:
between 4.0 and 7.0.
Related compounds
It meets the requirements of the test for Related compounds under Cromolyn Sodium Inhalation Solution, Nasal Solution being read in place of Inhalation Solution.
Assay
pH 7.4 Sodium phosphate buffer
Prepare as directed in the Assay under Cromolyn Sodium.
Assay preparation
Transfer 4 mL of Nasal Solution to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer an aliquot of this solution, equivalent to 8 mg of cromolyn sodium, to a 250-mL volumetric flask. Add 2.5 mL of pH 7.4 Sodium phosphate buffer, dilute with water to volume, and mix.
Standard preparation
Prepare as directed in the Assay under Cromolyn Sodium.
Procedure
Proceed as directed for Procedure in the Assay under Cromolyn Sodium Inhalation Solution.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2779
Pharmacopeial Forum: Volume No. 28(4) Page 1093
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